Meghana HN
Centralized Monitoring Assistant | Document Specialist | TMF Analyst |
Bengaluru
Summary
Results‑driven Centralized Monitoring Assistant & TMF Analyst with strong expertise in Clinical Trial Study Management, eTMF Operations (Wingspan & Veeva Vault) Project Support Coordination, and TMF Compliance & Quality Oversight. Skilled in end‑to‑end TMF management, document QC, indexing, reconciliation, metadata validation, archival, retrieval support, and maintaining audit‑ready TMF. Trusted for ensuring ICH‑GCP, SOP, and regulatory compliance, improving data quality, resolving discrepancies, and collaborating effectively with CRAs, CMs, CTMs, PMs, and CMS teams. Proficiently participated in project calls - KOM's , MOM's. Performed during processing user access requests, following up with vendors, and managing system access reconciliation with Consistently delivers high‑quality with timeline metrics that strengthens centralized monitoring and overall study oversight.
Overview
2
2
years of professional experience
4
4
Languages
Work History
CENTRALISED Monitoring Asistant
IQVIA
08.2025 - Current
- Completed role-specific training and followed CMA task lists to support study execution in accordance with ICH-GCP, SOPs, and regulatory requirements.
- Supported Clinical Monitoring Services (CMS) by running system-generated reports, preparing status trackers, and maintaining critical study documentation.
- Assisted in updating and maintaining CTMS and study-related systems within project timelines, ensuring the accuracy of visit dates, site details, KRIs, and milestone data.
- Reviewed site-level Key Risk Indicators (KRIs), past performance, and compliance analytics in alignment with the Central Monitoring Plan to identify early site-level risk.
- Escalated site performance concerns, non-compliance, and risk signals to Centralized Monitoring Specialists/Leads, and recommended corrective follow-up action.
- Prepared and maintained study trackers, PD logs, ICF tracking reports, non-compliance logs, and monitoring summaries to support continuous oversight of site operations.
- Generated i-site packs, monitoring packages, and required study reports for Clinical Managers (CMs), ensuring the timely availability of documents for review cycles.
- Performed access management tasks , including processing user access requests, following up with vendors, and managing system access reconciliation.
- Collaborated with Technical Solutions Specialists (TSS) on Excel-based validations, front-end configurations, and troubleshooting reporting discrepancies.
- Supported centralized monitoring activities by tracking study discrepancies, following up on outstanding issues, and documenting resolution status.
- Participated in project calls, Kick-Off Meetings (KOMs), and weekly team discussions to provide data insights, progress updates, and follow-up status.
- Ensured timely system updates, documentation integrity, and accurate study data to meet project-defined quality and timeline metrics.
- Maintained strong cross-functional communication with CRAs, CMs, CTMs, and data oversight teams to support the rapid resolution of data or site issues.
- Managed blast communications and performed timely TMF uploads in Wingspan for fixed and email-based documents.
- Updated LPV dates, shipment addresses, and site contact details in Veeva Clinical to maintain accurate study records.
- Generated and tracked daily CTMS reports, including Site Non-Compliance, Contact Reports, PD Reports, and ICF Tracking Logs.
- Prepared CTMS summaries of visit dates and windows for operational and stakeholder review.
- Extracted Study Item Export reports from Wingspan to support study tracking and reconciliation activities.
- Monitored RPA bot reports (AI outputs, CRA contact reports, visit letters, CRA metrics) to support centralized oversight.
- Conducted PD follow-up activities for France, Australia, and New Zealand, ensuring timely document closure.
- Supported payment review tasks and followed up on unfulfilled TMF placeholders to maintain completeness.
- Maintained global recruitment logs and IRT enrollment logs for accurate study enrollment performance tracking.
- Updated vendor trackers for system access and shipment status to ensure sponsor and study alignment.
- Maintained and updated CRA and CTA distribution lists for welcome communications and study-wide updates.
- Managed CTMS user access requests and performed access reconciliation based on approved email workflows.
- Generated additional CTMS reports, including CRA visit dates, contact details, summary visit windows, and monitoring dashboards.
- Created and maintained Insight Site Contact Lists and Action Item reports to enhance operational visibility.
- Performed TMF uploads from study emails, fixed documents, and follow-up communications to maintain eTMF quality.
- Ensured eTraining compliance, conducting follow-ups, and uploading training certificates to TMF.
- Maintained metrics trackers and updated master distribution lists for centralized periodic reporting.
- Updated the SRtE tool and ensured the accuracy of study milestone data.
- Supported access management across CTMS, DrugDev, RAVE EDC, LabCorp, Clario (eCOA), Smartsheet, Trifecta, Teckro, and Medidata (eCOA device shipments).
- Generated System User Access Reports for Clario and RAVE to support audits and compliance checks.
Document Specialist
IQVIA
02.2024 - 08.2025
- Performed end-to-end TMF management, including uploading, indexing, QC review, reconciliation, and lifecycle document handling, ensuring all files meet ICH-GCP, SOP, and regulatory compliance standards.
- Executed document imaging, scanning, and metadata accuracy checks, supporting orderly transfer, retention, and final archival of trial documentation in alignment with IQVIA records management procedures.
- Conducted file accuracy reviews, verifying completeness, correct filing location, duplicate control, and adherence to sponsor/IQVIA file plans before approving content for the TMF.
- Coordinated document retrieval requests, supporting clinical teams, auditors, and inspectors by quickly locating, providing, and updating on TMF records.
- Administered eTMF systems such as Wingspan and Veeva Vault, ensuring proper metadata tagging, correct file classification, and compliant document handling across multiple studies concurrently.
- Supported the disposition, archival, and transfer of closed studies, including the preparation of inventory checks and the destruction of obsolete records, according to retention policies.
- Maintained records center security, controlled access permissions, and monitored compliance with document handling guidelines to preserve integrity and audit readiness.
- Trained new team members on scanning processes, filing standards, TMF structure, and records management procedures, improving departmental consistency and quality.
- Interfaced with cross-functional teams (CRAs, CTMs, PMs) to ensure timely document submissions, resolve filing discrepancies, and maintain on-schedule TMF completeness for inspections.
- Performed daily monitoring of document flows, supporting project deadlines, identifying delays, and ensuring documentation throughput aligned with project timelines and quality expectations.
- Collaborated on records management workflow improvement initiatives, recommending updates for scanning accuracy, indexing, storage utilization, and documentation efficiency.
- Performed continuous document QC and TMF updates, including email-based filing, fixed document uploads, and metadata management in Veeva Clinical and Wingspan.
- Generated and validated study documentation reports, such as ICF logs, non-compliance logs, PD reports, and monitoring summaries, support documentation completeness and traceability.
- Ensured accurate document metadata, including site details, visit dates, shipment records, and contact information across CTMS and eTMF systems.
- Conducted placeholder tracking and closure, resolving missing-document issues, and ensuring audit-ready TMF.
- Supported record retrieval requests, CRA follow-ups, and cross-department information needs, mirroring TMF support functions described.
- Ensured audit-ready eTMF by executing comprehensive reviews aligned with ICH-GCP, regulatory guidelines, and SOPs; completed department, internal, country, and investigator file checks across multiple complex studies, including migrations and multi-arm trials.
- Accelerated site activation by coordinating, reviewing, and filing critical documents (SEF, insurance, regulatory submissions), performing TMF reconciliation, and managing placeholders to maintain document completeness and accuracy.
- Supported regulatory submissions (CDA, CTA, IEC/IRB approvals), and processed expedited safety reports (AEs, SAEs); maintained local regulatory trackers, ensuring 100% compliance with country-specific requirements.
- Delivered system and data quality support by maintaining up-to-date eTMF databases, performing reconciliation, generating study metrics, supporting UAT cycles, updating SharePoint, and suggesting workflow automations to improve operational efficiency.
- Strengthened trial administration by managing study documentation, ensuring timely eTMF uploads, coordinating translations, preparing agendas and minutes, managing mass mailings, and escalating compliance risks as needed.
- Improved team communication and risk mitigation by proactively addressing site issues, ensuring effective follow-up, and contributing to on-time, on-budget delivery of study milestones.
- Managed vendor and site documents, maintaining trackers, ISF, pharmacy binder materials, non-clinical supply distribution, and supporting feasibility and site-readiness activities using regional insights.
- Acted as an onboarding buddy, training new team members on trial processes, SOPs, and system usage; contributed to feasibility process rollouts, and RBM support activities.
- I performed technical QC on all eTMF documents, including scanning standards, legibility, completeness, and duplicate control, communicated quality findings to importers, and approved documents for the next stage of lifecycle progress.
Education
M.Pharm -
Government College of Pharmacy
Bengaluru, India 04.2001 -
B.Pharm -
Shree Siddaganga College of Pharmacy
Tumkūr, India 04.2001 -
Skills
Team worker
Good communication
Critical Thinking
Organizational and time-management skills
Analytical and decision-making s
Cross- functional team management
Essential Judgment
Query Resolution
Problem Solving
Team Collaboration
Certification
• Internship: Liveon Biolabs Pvt.Ltd, Tumakuru, Handling of animals.
• Carried out Project on the topic of Development of topical herbal formulation Comprising extracts of Vanda Coerulea and Decalepis Hamiltonii and it’s evaluation for Anti-Acne properties.
• Presented Poster presentation at 1st International Conference on Healthcare and Technical Research, Manipal University.
• Presented Poster presentation at 24th Indo-US International on Worldwide Trends and Current Challenges in Herbal and Pharmaceutical Technology at Mallige college of pharmacy Bengaluru.
• Participated National Conference on Recent advances in Pharmaceutical Sciences at IIMT College of Pharmacy, Noida.
• Participated Rural IT Quiz National Finals, Bengaluru.
Tools
Tools: Worked on Veeva vault, eTMF Upload and review, CTMS, Adobe Acrobat, Nitro PDF SharePoint, CRF. SGL tool,
Technical skills
MS Office (Word, Excel, PowerPoint), Outlook | ALCOA+ | Documents Tracking and Reconciliation | I-eTMF Systems| Veeva vault | CTMS | Regulatory knowledge – ICH-GCP guidelines | FDA and other regulatory guidelines. | Fully knowledge on essential documents of clinical trial | Document management and Quality Assurance Metadata tagging | Site Green lite Tool | i-site packs | q-archive |
Achievements
• Awarded ‘Spotlight ’Award for Highest uploader and maintaining error rate less than 1% error and 125% productivity.
• Represent IQVIA in multiple sports activities like Throwball, Cricket and awarded with runner-up.
• Ranked 63rd in Karnataka PG-CET -2022.
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge. I am willing to relocate if necessary.
Timeline
CENTRALISED Monitoring Asistant
IQVIA
08.2025 - Current
Document Specialist
IQVIA
02.2024 - 08.2025
M.Pharm -
Government College of Pharmacy
04.2001 -
B.Pharm -
Shree Siddaganga College of Pharmacy
04.2001 -